Efficacy and Safety Evaluation of SMO1 in Patients With Retinal Vein Occlusive Macular Edema

A Multicenter, Randomized, Double-blind, Parallel Design, Active-controlled Phase 3 Study to Determine Efficacy and Safety Following Administration of SMO1 in Patients With Retinal Vein Occlusive Macular Edema

This is a multicenter, randomized, double-masked, parallel-group, active-controlled Phase 3 clinical trial designed to evaluate the efficacy and safety of SMO1 (Dexamethasone 700μg intravitreal implant) compared with the reference drug (Dexamethasone 700μg intravitreal implant) in patients with retinal vein occlusion (RVO)-associated macular edema.

Participants are randomized in a 1:1 ratio to receive either the reference drug or the investigational product, SMO1, following screening and baseline assesments. Randomization is centrally managed and stratified by RVO subtype (branch or central). Patients are followed for 6 months with scheduled visits to assess efficacy and safety endpoints. A total of 312 participants (156 per treatment arm) will be enrolled.

Study Overview

• Status: Recruiting
• Conditions: Retinal Vein Occlusion With Macular Edema
• Intervention / Treatment: Drug: Reference Drug; Drug: SMO1

• Study Type: Interventional
• Enrollment (Estimated): 312
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nahyun Kang, Ph.D; Phone Number: +82 2-3489-6298; Email: nahyun.kang@sminnovation.com

Study Locations

• South Korea
  • Gangdong-gu
    • Seoul, Gangdong-gu, South Korea, 05278
      • Recruiting
      • Kyung Hee University Hospital at Gangdong
      • Contact: CRC Park; Phone Number: +82 2-440-7065; Email: messenger012@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 19 years of age or older
• A study eye diagnosed with macular edema following i) branch retinal vein occlusion (BRVO) within 12 months prior to the screening visit or; ii) central retinal vein occlusion (CRVO) within 9 months prior to the screening visit
• A study eye with CRT measured to be 300μm or greater using OCT at the screening visit
• A study eye with BCVA between 34 and 68 letters at the screening visit and the baseline (comparable to Snellen score between 20/200 and 20/50)
• Provided written informed consent voluntarily after receiving a full explanation of the clinical trial

Exclusion Criteria:

• A study eye with visual improvement determined to be highly unlikely due to the baseline condition of the eye
• A study eye with macular edema caused by the formation of an epiretinal membrane or visual improvement determined to be highly unlikely even if the macular edema decreases
• A study eye with uncontrolled glaucoma with intraocular pressure of 25mmHg or higher despite medical treatment at the screening visit
• A study eye with severe media opacity such as corneal opacity, cataracts, or vitreous hemorrhage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reference Group; Treatment: Reference Drug (Dexamethasone 700μg Intravitreal Implant) Pre-treatment: Ofloxacin (3mg/mL) Eye Drop	Drug: Reference Drug; Pre-treatment: Ofloxacin Eye Drop TID for 3 days before and after the administration of the reference drug (Day -3 ~ 3).; Single administration of the reference drug at Day 0.
Experimental: SMO1 Group; Treatment: SMO1 (Dexamethasone 700μg Intravitreal Implant) Pre-treatment: Ofloxacin (3mg/mL) Eye Drop	Drug: SMO1; 1. Pre-treatment: Ofloxacin Eye Drop TID for 3 days before and after the administration of the reference drug (Day -3 ~ 3). 2. Single administration of SMO1 at Day 0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity (BCVA) at Month 2	Change in BCVA score from the baseline, at Month 2 after the administration of the investigational drug using early treatment diabetic retinopathy study (ETDRS) chart	Month 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA at Month 1, 3, and 6	Change in BCVA score from the baseline, at Month 1, 3, and 6 after the administration of the investigational drug using ETDRS chart	Month 1, 3, and 6
BCVA improvement of 15 letters (3 lines) or more	Proportion of patients with BCVA improvement of 15 letters (3 lines) or more compared to the baseline using ETDRS chart, at each post-administration visit (Month 1, 2, 3, and 6)	Month 1, 2, 3, and 6
Central retinal thickness (CRT) at each visit	Change in CRT compared to the baseline measured with optical coherence tomography (OCT), at each post-administration visit (Month 1, 2, 3, and 6)	Month 1, 2, 3, and 6

Collaborators and Investigators

• Sponsor: SANGMYUNG innovation

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: July 12, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SMO1-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No